ACS ESTADIOL-6 II by CHIRON DIAGNOSTICS CORP.

The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradial in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS:180 automated chemiluminescence systems.

Device Description

Not Found

AI/ML Overview

This is a difficult request to fulfill accurately. The provided text is a 510(k) clearance letter from the FDA for a medical device (Chiron Diagnostics ACS:180 Estradiol-6 II Assay). While it mentions that the device is "substantially equivalent" to previously marketed devices and permits marketing, it does not contain the detailed study information, acceptance criteria, or performance data that would be typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.

The document primarily focuses on the regulatory clearance process and confirms that the device can be marketed. It does not provide the specifics of the underlying studies that demonstrated performance or met acceptance criteria.

Therefore, I cannot extract the requested information directly from the provided text. To answer your questions, I would need a different type of document, such as:

A Clinical Study Report (CSR)
A Summary of Safety and Effectiveness Data (SSED), often found in FDA device approvals (though less common for a 510(k) without major new technology).
A detailed 510(k) submission summary that includes performance data.

Based on the provided text, I can only state that:

Acceptance criteria and reported device performance: Not explicitly stated in terms of quantitative values or specific assays. The letter only broadly implies that performance was deemed "substantially equivalent" to predicate devices.
Sample size, data provenance: Not mentioned.
Number of experts and qualifications: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study: Not mentioned. This device is an immunoassay, so an MRMC study is highly unlikely to be relevant.
Standalone performance study: The nature of this immunoassay suggests it would primarily be evaluated in a "standalone" fashion (i.e., algorithm/device only, producing a quantitative result). However, the specific details of such a study are not provided.
Type of ground truth: For an immunoassay, the "ground truth" would typically be established through highly accurate reference methods or other well-validated laboratory methods. This is not detailed in the provided text.
Sample size for training set: Not mentioned. This device is a pre-AI era immunoassay; the concept of a "training set" in the modern AI sense is not applicable.
How ground truth for training set was established: Not applicable in the AI sense.

In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical and clinical study information required to answer your questions.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an emblem that appears to be an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 4 1997

Thomas F. Flynn Manager, Regulatory Affairs & Compliance Chiron Diagnostics Corporation 63 North Street Medfield, Massachusetts 02052-1688

K970386 Re: ACS Estradiol-6 II Immunoassay Requlatory Class: I Product Code: CHP Dated: January 31, 1997 Received: February 3, 1997

Dear Mr. Flynn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 320) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Company Confidential

Page

510(k) Number (if known):

Device Name: Chiron Diagnostics ACS:180 Estradiol-6 II Assay

Indications for Use:

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K970586

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use لل (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

ACS:180 Estradiol-6 II 510(k)

June 2, 1997

Regulation Number and Section

§ 862.1260 Estradiol test system.

(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.